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COVID-19 epidemic continues to spread in the globe, and over the past year, the number of newly confirmed COVID-19 cases overseas continued to increase, and the situation is still severe now. Appearance of the mutant strains will accelerate the spread speed of the epidemic. COVID-19 vaccine is the most important means for controlling the COVID-19 epidemic, and vaccination is being actively promoted worldwide. In order to improve procurement efficiency of COVID-19 vaccine manufacturers, and enable them to make batch production of COVID-19 vaccines as early as possible, TRUKING TECHNOLOGY put all its resources to complete equipment delivery of overall solution of vial compact line and other main production equipment in merely 30 days.

At present, 7 medical COVID-19 vaccines have been put into production using TRUKING equipment in China, including inactivated vaccine, adenovirus vector vaccine and recombinant protein vaccine. Manufacturers of COVID-19 vaccines in China not only supply the vaccines to Chinese market, but also meet demands of overseas markets, thus having a great pressure in terms of Production capacity on the whole. For the COVID-19 vaccine filling production line supplied by TRUKING TECHNOLOGY to vaccine manufacturers in China, its production speed is up to above 500 pcs/min stably, thus having greatly relieved production capacity pressure of the vaccine manufacturers, therefore, in high-speed vaccine production line market in China, about above 80% Chinese vaccine manufactures select TRUKING as their strategic partner.

Characteristics of TRUKING Vial compact line

?Follow regulatory requirements of cGMP, EU-GMP and FDA;

?Excellent industrial aesthetic design, and good human-machine interface;

?Sterile design according to GMP concept, easy to clean, easy to operate and easy to maintain;

?Flexible layout solution;

?Tool-free plug-in mold change parts that can be replaced quickly;

?Documentation system meet GAMP5 level, control system meets 21 CFR part 11.

?The batch record and batch report meet requirements of computerized system.

Overall upgrading of equipment appearance

?The complete line appearance with neat and uniform design which largely improves the appearance quality and aesthetic perception.

?Optimize and improve poor appearance of all equipment, to improve aesthetic image of all equipment.

?Add color printing acrylic board and lamp belt, to improve layering sense of the appearance on the whole.

Improvement of equipment performance

?ISA88 program framework

The whole-line program is designed following OMAC (Organization of Mechanical Automation and Control) standard and adopting Siemens’ CPG (Consumer Package Goods) template based on OMAC PackML, which meets international unified industrial standard. All whole-line equipment adopts ISA88 architecture, standard communication interface, and unified mode management and equipment status management. It reduces spare parts for software and hardware and lowers the fault risk, to improve controllability of quality.

?Pre-maintenance function of core parts

The whole line provides pre-maintenance function, makes operation statistics of key valves, motors and other key process parts, and gives early maintenance warning, to reduce production risk.

?OEE (overall equipment effectiveness) analysis

Make statistics of six major equipment conditions which could cause loss: machine down-time, adjustment and setting time, idle time, speed drop, rejection rate, and startup damage.

Make real-time analysis of integrated benefit of each piece of equipment and operation efficiency of the whole line;

Help the users make reasonable overhauling, optimize production scheduling, and realize lean production.

?The Vertical ultrasonic washing machine adopts automatic drainage technology for the first time, which realizes easy one-click drainage, thus having reduced the labor intensity and improved customer experience;

?Control of Water and air spraying time and circulation water temperature

Water and air spraying time of the vial washers can be controlled via formula directly, while circulating water temperature can be controlled by the upper and lower setting limits and the upper and lower alarm limits. When the temperature is below the lower setting limit, the Heater in the bottom water tank will start heating, while when the temperature is above the upper setting limit, the heater will stop heating; there is a certain value difference between the upper and lower setting limits and the upper and lower alarm limits, and the circulating water temperature shall be Controlled between the upper and lower alarm limits.

?Washer high speed feeding technology for large size vials

The vial washers adopt brand-new single-row vial-feeding + parallel track spraying method, which has increased the vial washers’ large size via speed from 60pcs/min to 100pcs/min, and improved operation efficiency of the equipment by 67%.

?Feedback technology for water-air joint control

This technology has resolved the washer spraying needle without block detection function problem. It will get accurate feedback of pressure from the pipeline with the pressure transmitter to know the flow condition inside the pipeline. Also, it can avoid the machine running without the control valve not open which will ultimately affect the cleaning efficiency. It achieves all the internal/external spraying's pressure detection.

?The ultrasonic washing machine adopts low-friction protection technology, which guarantees the vials without scratch at the out-feed station.

?The Sterilizing & drying tunnel assembles pipelines of the Conveyor belt and the surface cooler at the lower section of preheating zone to facilitate connection of the customer’s pipelines

?Forced air compensation technology in high-temperature zone

KSZ1200 model forms forced air compensation by adding fan-filter system in the air compensation location, which is more convenient to regulate the pressure difference in high-temperature section; forced air compensation can increase exchange efficiency of internal humid and hot air, and enable a higher temperature rise efficiency of bottles; at the end of production, the inside of the tunnel cools faster than natural air compensation.

?The sterilizing tunnel external cover with design to hidden the machine base frame and also convenient for the end client to do sealing to the floor after installation.

?The filling & stoppering machine before filling is available to configured with Pre-inspection technology

Before filling, the AR foreign-particle visual inspection system can detect glass particle fibers, black spots, white spots and other defects inside the vials effectively; For the abnormal vials, it will pass the machine without filling and stoppering automatically, so as to avoid waste of liquid medicine; it can also eliminate abnormal empty vials automatically.

1.Main testing contents and precision:

?The glass size up to 0.5mm×0.5mm;

?Hair and fiber size <50μm, the detecting precision is related with its color;

?For cracks at the bottom of the vial, the testing precision is related with the crack positions, depth and length;

?Other foreign particles which size is within the detectable range;

2.Production capacity: it matches with the washing, drying and filling production line (up to 600 pcs/min at the highest);

3.It is equipped with auto-rejecting function;

4.It is equipped with counting, Data saving, testing report, three-level authoritarian and other functions.

?Intelligent emptying and Smart tail-liquid filling technology

Filling technology has always been an important core part in filling production line of sterile injections, and high value-added injection drugs must meet high standards during the filling production process, as well as the stability and reliability requirement for filling precision. It is very important as for how to realize automatic calibration of filling amount in the production preparation stage with minimum or even zero liquid loss; how to guarantee non-drifting of the filling amount and realize process quality control of 100% filling amount during the filling production process; how to empty tail liquid with the minimum residue or even reduce the material loss to the amount of a vial in Empty Mode at the end of the filling production stage, however, for traditional filling technology, there will generally be tens and even a hundred of vials with non-conforming filling amount per batch, as well as filling vials with high value-added or multiple batches, causing the pharmaceutical enterprises to have a product value loss up to several millions yuan every year.

TRUKING TECHNOLOGY’s European Institute of R & D and Central Institute of R&D have gathered multi-disciplinary engineers such as mechanical engineers, automatic control engineers, CFD engineers, and AI engineers, etc., and they have achieved technological breakthrough upon accumulation and repeated verification of the joint researches in recent two years, and successfully developed near-zero-residue Smart Filling automatic emptying filling system and software technology, which can perfectly control minimization of liquid residue, and enable maximization of economic benefit of pharmaceutical enterprises.

In the production preparation stage, fluid dynamics model and AI technology are used to make automatic filling according to different conditions of each filling pump, and make calculation in combination with intelligent high-precision weighing system, and it can be configured with fluid-supplement filling technology to guarantee filling amount of each vial within acceptability limit. After a period of normal production, in case of alarm due to excessive low liquid level of the buffer tank, tail-liquid filling mode shall be enabled, and upon in-depth study and big data analysis, if the liquid in the buffer area becomes less and less, the filling amount will take on non-linear change, and by the unique tail-liquid filling technology, it can realize zero liquid residue in the buffer tank, dispenser, silicone tube and filling head of the whole filling system, as well as minimization of liquid residue in a perfect way.

TRUKING TECHNOLOGY’s Smart Filling-automatic emptying and tail-liquid filling technology breaks through technological bottleneck, and has become the unicorn technology for products of TRUKING TECHNOLOGY’s vials linkage line to compete with advanced products both at home and abroad, it can be used for filling of high-end bio-pharmaceuticals and other drugs, and can greatly improve automation and intelligence degree of the equipment, so as to improve economic benefit per single batch of production for high-end bio-pharmaceutical enterprises.

Freeze-dryer auto loading & unloading system come into use in early 1980s, and it is a full-automatic connection equipment that uses automation technology to complete half-stoppered vials from the filler to the freeze dryer, and then from the freeze dryer to the capping machine under the premise of meeting regulations. Upon several decades of development, it has formed several types as follows: Moveable auto loading & unloading system, Fixed row by row auto loading & unloading system, Mixed type auto loading & unloading system. Where, Fixed row by row auto loading & unloading system has been generally adopted by pharmaceutical enterprises and is most widely used since it has the advantages such as high automation, good repeatability, easy to verify, guarantee of stable and reliable product quality, and minimization of product contamination, etc.

With increasingly strict regulations, the pharmaceutical enterprises put forward a higher requirement for production cost, production efficiency and sterile guarantee of products, and the Auto loading & unloading system at present is also subject to challenges as follows:

1.Since the plant space is limited, how to lay out the automatic feeding and discharging?

2.How to avoid the loading pusher contamination risk when cross Grade A/ Grade B? /How to make sterile verification of the loading pusher bellows? /How to guarantee product sterility if laminar flow pattern in the location of loading pusher does not meet standard?

3.Since the order demand is big, how to improve the production capacity?

TRUKING TECHNOLOGY has always been adhering to the concept of being the “sole or first”, keeping forging ahead, and dedicated to providing the customers with efficient, stable and perfect solutions. Over many years of investment and innovation, it has successively launched integrated solution for biological lyophilization automatic feeding & discharging, integrated solution for RGV lyophilization automatic feeding & discharging, solution for APIs sterile lyophilization automatic feeding & discharging, solution for APIs tray lyophilization automatic feeding & discharging, and solution for non-sterile food lyophilization automatic feeding & discharging. The α-ALUS series of automatic loading & unloading system is another generation of product launched by TRUKING TECHNOLOGY.

Characteristics of α-ALUS system:

1.Flexible layout solution

?Area of Grade B is reduced by 70%, and the operation cost is reduced

?Widen the people and material flow channels

?It can meet auto loading & unloading system demand of single or multiple freeze dryers

?It is applicable to integrated lyophilization solution for different scale of Lab, pilot and production purpose

?It can be integrated with ORABS, CRABS and ISOLATOR systems

2.Sterility compliance

?Embedded loading pusher different scale of Lab, pilot and production purpose module

?Design of pusher-free bellows

?Reliable isolation and leak-proof structure

?Perfect airflow pattern in core area

?Clean control in critical areas

3.Efficient and stable loading pusher mode

?Loading speed: 600VMP

?Continuous pushing mode

?Double-push design, single-row push loading and whole-plate loading cooperate with division of labor

?There is no S-shaped cache area, which reduces vial-loading path

?Big star-gear design, which improves the vial-counting efficiency

The α-ALUS series of automatic loading & unloading system is a future-oriented solution for feeding & discharging of freeze dryer. It not only is characterized by small space, flexible layout, good sterility compliance, intelligent and efficient feeding, etc., but can also form integrated lyophilization solutions in cooperation with LYOTK-type industrial, bench and pilot freeze dryer and different RABS forms. It can effectively reduce investment cost of the equipment, and maximize use value of the whole line.

?Control of the biggest risk point in lyophilization production –TRUKING’s advanced shelf processing technology

Application of lyophilization technology started in early 1980s. Lyophilization refers to the method that freezes Liquid into solid by pre-cooling, and then sublimates water directly from solid into water vapor to obtain drying under the vacuum condition. Shelf is the core part of freeze dryer. It is the shelf used for storing products in the freeze-drying chamber during lyophilization process, and cooperates with the loading & unloading system to realize the products’ loading & unloading of the freeze-drying chamber, and in the meantime, the surface of the shelf is in direct contact with the product or product container, and it is also used for even heating and cooling of products.

In November 2019, TRUKING’s digital intelligent automatic welding line established a process digital traceability system that covers whole production cycle of shelfs. With digital tracking number as the core, it can meet shelf’s auxiliary feeding, automatic feeding & discharging, laser labelling, logistics transshipment, welding, automatic unit-polishing, automatic material-cleaning, leveling, sanding, flatness and roughness test, automatic integration and quality traceability function in the transformation and production process, and intelligent material delivery during station production process of the whole line. The functions are described in details as follows:

1.Autogenous welding of shelf and edge steel

After completing splicing of shelf and edge steel, the frames shall undergo welding process, which is the most core process during the shelf processing, and it decides quality of shelfs directly. Manual welding is traditionally adopted, which has poor quality uniformity and great labor intensity, and the noise, strong light and dust, etc. can cause pollution to the welding personnel and environment, therefore, digital shelf processing line adopts robot laser welding process to replace original manual welding.

Automatic welding of shelfs adopts laser tracking principle, and follows the laser triangulation measurement principle: three parallel laser beams project onto the surface of the base material at a slant angle of 20 degrees, and generate deformation on splicing edge of the weld; in the meantime, a digital camera is used to scan the work area, collect and process the data of laser rays, thus determining the weld location.

By virtue of this welding method with automatic tracking and stable output current, it has solved the industrial difficult problems with manual welding of shelfs such as poor-quality uniformity, low efficiency, great labor intensity, severe pollution, as well as great difficulty and poor quality stability with automatic welding of Grade I shelf stainless steel weld.

2.chamber structure design

The cavity is shaped by an integral plate with rounded corners, and the whole cavity has only one welding joint. There is no risk of leakage.

3.The isolator, the freeze dryer and Sterilizing & drying tunnel are connected by full-length welding process, which have no risk of leakage, and do not require regular maintenance.

4.Shelf welding by vacuum brazing

At present, our company uses vacuum brazing for welding of shelfs. In the form of hollow square tube, it makes pot welding of the brazing solder to the hollow square tube, and then welds the square tube with the solder to the board, and uses crossers to have close contact with the board, places them in vacuum brazing furnace, and then connects the upper and lower boards with the square tube under vacuum and high temperature in accordance with the vacuum brazing process, and then upon completion of brazing, makes welding of surrounding places of the shelf. Compared with manual argon tungsten-arc welding and drilling plug welding methods, vacuum brazing has smaller welding deformation and quicker welding speed, as well as thinner board and better heat-conducting performance of the shelf.

5.Integrated cleaning and drying process of shelfs

During welding process of shelfs, the surface cleaning is a very important process. Poor cleaning will make it easy to cause poor welding quality, sand hole in the weld and other problems. Traditional cleaning process relies on artificial immersion and scrubbing, which is a waste of time and energy, besides, the residual water on the shelfs are difficult to dry, and the whole process will require 65min on average; however, in automatic welding process, integrated cleaning and drying process of shelfs is added, which is equipped with high-pressure spray nozzle and drying & heating tube, enabling the whole process to make thorough cleaning and quick drying; the operation speed of shelfs on the integrated machine is set at 25cm/min, and the whole process will take no more than 35min.

6.Double-motor station sander

Traditional sander only has one polishing station, and the board-layer undergoes polishing once only; while in automatic welding process, the polisher has two polishing stations, which can enable the board-layers to undergo back-and-forth polishing in the sander, thus having higher production efficiency.

7.Intelligent digital online testing

Upon completion of sanding, the board-layer shall undergo flatness test and roughness test. After passing the flatness test and roughness test, the board-layers shall be off the line by stacking, and then processing of board-layers is completed.

8.Automatic welding process technology of board-layers

Compared with traditional manual welding process, it has solved industrial difficult problems with board-layers such as the quality uniformity is poor, welding of Grade I board-layer stainless steel weld is of great difficulty and the welding quality is of poor stability, and has effectively improved overall quality of biological freeze dryer, and it is also equipped with obvious technology and cost advantages as follows:

1)The number of personnel configured for board-layer and edge steel welding process is reduced from 4 to 3, and the labor cost is reduced by 25%;

2)With breakthrough of process technology as well as reduction in welding time, cleaning time and polishing time, etc., production efficiency per day is improved by 50%;

3)Lump-sum leakage detection pass rate of board-layers is improved from 90% to 100%;

Having been in sincere development for 21 years, TRUKING’s investment in research and development accounts for 30% of its total investment, and it maintains constant innovation and perfection of products, and guarantees globally leading technology as well as globally leading quality. Under the premise of guaranteeing product quality, TRUKING realizes quick delivery of project, establishes service centers all over the globe, makes quick after-sales service response, and provides one-stop turnkey projects for its customers. In addition to integrated solutions for water-needle lyophilization, we are also capable of providing integrated solutions for bioengineering, TCM engineering, sterile preparation, solid preparation, testing and secondary packaging, water for pharmaceutical use, EPCMV service, and intelligent manufacturing, etc.